BEUDAMED
    FDA Recall Terminated

    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray

    Recall: Z-0733-2017 · Initiated November 28, 2016

    Recall

    Recall Number
    Z-0733-2017
    Event Number
    75793
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 28, 2016
    Posted
    December 12, 2016
    Terminated
    September 6, 2017
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray

    Reason

    Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.

    Action

    Cook Medical sent an Urgent - Medical Device Recall letter dated November 23, 2016. to all affected customers. The letter identified the product the problem and the action needed to be taken. Action to be taken: 1. Please review the attached list of affected products and lot numbers that were shipped to your account and quarantine any affected products that remain unused. 2. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. 3. Please complete the attached Acknowledgement and Receipt Form and return it to Cook Medical. 4. Please report any adverse event to Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235, Monday through Friday between 7:30 am and 5:00 pm Eastern Standard Time or e-mail at [email protected]. Transmission of this notice: This notice must be passed on to appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred. Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.

    Distribution

    AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI

    Quantity

    99 units